Senior Principal Medical Writer

EMD Serono Research & Development Institute•Billerica, MA

6d•$126,900 - $215,400•Hybrid

About The Position

Work Your Magic with us! Start your next chapter and join EMD Serono. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. As the Senior Principal Medical Writer, you will lead the end-to-end development of complex regulatory submission documents – ensuring high communication quality, scientific rigor, regulatory compliance, and timely delivery across international markets. Acting as the primary medical writing lead within cross-functional teams, you will define document strategy, shape submission timelines, and align stakeholders across clinical, regulatory affairs, pharmacovigilance, and statistics. Beyond your individual contributions, you will mentor and develop fellow writers, champion best practices, and drive consistency and quality across deliverables. This is a role for a seasoned professional who combines deep medical writing expertise with the ability to influence decisions, lead without authority, and deliver with precision on programs that directly advance patient health.

Requirements

Bachelor’s degree in a scientific or writing discipline; Master’s or PhD preferred.
5–8 years of relevant medical writing experience in pharma/biotech, with strong regulatory documentation background.
Proven ability to lead multiple writers and coordinate vendor resources for regulatory submissions (IND/IMPD, bridging documents, briefing books, etc.).
Solid CTD/CTD-like knowledge; experience across multiple markets is a plus.
Excellent written and verbal English; strong presentation and collaboration skills.
Ability to travel as needed.

Nice To Haves

Experience with country-specific submissions and post-approval documents
Proficiency with document management systems, SharePoint, and standard MW templates
Familiarity with industry best practices and evolving regulatory guidelines
Strategic document planning and cross-functional leadership
Deep knowledge of regulatory submission requirements and lifecycle management
Vendor management and remote leadership
Strong communication, negotiation, and stakeholder management
High attention to quality, accuracy, and compliance

Responsibilities

Lead medical writing efforts for global, priority programs across the full regulatory documentation suite (protocols, clinical study reports, Investigator’s Brochures, briefing books, clinical summaries, pediatric plans, authority responses, etc.).
Act as Lead Writer/oversight for clinical sections of regulatory dossiers (eCTD) for global market approvals.
Represent Medical Writing in cross-functional teams; participate in governance and project meetings.
Define and implement document strategy, resource needs, and timelines; manage deliverables from vendors and external writers as needed.
Mentor and develop writers; drive adoption of MW best practices and standards.
Manage documentation strategy, quality, and consistency across indications; ensure alignment with regulatory expectations.
Coordinate with cross-functional teams (clinical, pharmacovigilance, regulatory affairs, statistics) to ensure timely and compliant delivery.